Oral product

ABSTRACT

An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and a mouth-soluble binder dispersed in the mouth-stable polymer matrix.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit under 35 U.S.C. 119(e) to U.S.Application No. 61/822,596, filed on May 13, 2013.

TECHNICAL FIELD

This document relates to oral products including mouth-stable polymersand one or more additives.

BACKGROUND

Tobacco can be enjoyed by adult tobacco consumers in a variety of forms.Smoking tobacco is combusted and the aerosol either tasted or inhaled(e.g., in a cigarette, cigar, or pipe). Smokeless tobacco products arenot combusted and include: chewing tobacco, moist smokeless tobacco,snus, and dry snuff. Chewing tobacco is coarsely divided tobacco leafthat is typically packaged in a large pouch-like package and used in aplug or twist. Moist smokeless tobacco is a moist, more finely dividedtobacco that is provided in loose form or in pouch form and is typicallypackaged in round cans and used as a pinch or in a pouch placed betweenan adult tobacco consumer's cheek and gum. Snus is a heat treatedsmokeless tobacco. Dry snuff is finely ground tobacco that is placed inthe mouth or used nasally.

A growing number of governments are now implementing restrictions onsmoking in public places, such as restaurants and transport facilities.In some countries, such as the United States, some workplaces are alsocovered by public restrictions. Smokeless products may also be banned bycertain governments or workplaces.

Trans-buccal systems such as nicotine-containing chewing gum as well astransdermal nicotine delivery systems are well known in the art. Thesesystems, however, do not consistently provide a suitable tobacco-likeexperience for some adult tobacco consumers.

Oral products providing flavor and/or one or more active ingredients arealso known. One such oral product is chewing gum. Other oral productsinclude hard candies (e.g., mints). Softer gelatin-based oral productsare also known. Pharmaceutical and therapeutic products (e.g.,cough-suppressant lozenges) can also be provided in a solid form fororal consumption. The flavor release and/or active agent releasecharacteristics for an oral product are important for providing animproved consumer product.

SUMMARY

This specification describes an oral product that includes amouth-stable polymer matrix, cellulosic fibers, and one or moremouth-soluble binders. The oral product can provide a satisfying tactileand/or flavor experience. The oral product can include one or moreadditives, such as an active ingredient, a flavorant, a sweetener, or acombination thereof. In some cases, the cellulosic fibers can includenatural active ingredients and/or flavors. In particular embodiments,the oral product can provide an extended additive/active/flavor releasetime. The oral product includes a body that is at least partiallyreceivable in an oral cavity of an adult consumer. In some embodiments,a body includes a mouth-stable polymer matrix, cellulosic fibersembedded in the stable polymer matrix, and the binder dispersed withinthe body.

The mouth-soluble binder can be a carbohydrate, protein, or combinationsthereof. In some embodiments, the mouth-soluble binder includes ahydroxyl containing compound, a dextrin or dextrin derivative,carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethylcellulose, hydroxypropyl methyl cellulose, methyl cellulose, konjac,collagen, inulin, soy protein, whey protein, casein, wheat gluten,carrageenan, alginates, propylene glycol alginate, xanthan, dextrin,pullulan, curdlan, gellan, locust bean gum, guar gum, tara gum, gumtragacanth, pectin, agar, zein, karaya, gelatin, psyllium seed, chitin,chitosan, gum acacia, polyvinyl pyrrolidone, polyethylene oxide,polyvinyl alcohol, pectin, or a combination thereof. In certainembodiments, the mouth-soluble binder is selected from the group of guargum, xanthan, cellulose, and combinations thereof. For example, oralproducts can include between 0.05 and 1.0 weight percent of a binderthat includes guar gum, xanthan, and carboxymethyl cellulose. In somecases, oral products provided herein can include between 0.2 weightpercent and 0.5 weight percent binder. The binder can provide the oralproduct with a modified texture and flavor release profile. The oralproduct, according to certain embodiments, includes nicotine or aderivative thereof. The oral product can provide a tobacco-like flavorexperience and favorable tactile experience. Combinations of additives(e.g., sweeteners, flavorants, and nicotine) can be combined to providea favorable tactile and flavor experience.

The oral product, according to certain embodiments, includes flavorants,sweeteners, vitamins, minerals, therapeutic agents, nutraceuticals,energizing agents, soothing agents, coloring agents, amino acids,chemsthetic agents, antioxidants, food grade emulsifiers, pH modifiers,botanicals, teeth whitening agents, and/or alkaloids (e.g., caffeine).In some cases, the oral product can be substantially free of tobacco.Combinations of additives (e.g., sweeteners, flavorants, and caffeine)can be combined to provide a favorable tactile and flavor experience.

In some cases, the cellulosic fibers can be tobacco fibers. An oralproduct including tobacco fibers can include a body that is at leastpartially receivable in an oral cavity of an adult tobacco consumer. Insome embodiments, the body includes a mouth-stable polymer matrix,tobacco fibers embedded in the stable polymer matrix, and a binderdispersed in the body. The tobacco fibers dispersed in the body canprovide an adult tobacco consumer a satisfying tactile and/or flavorexperience. In some embodiments, an oral product can includeexhausted-tobacco fibers and one or more additives.

These and other embodiments can each optionally include one or more ofthe following features. In some embodiments, the oral product's bodyincludes at least 10 weight percent of the mouth-stable polymer. Themouth-stable polymer matrix can include polyurethane, silicon polymer,polyester, polyacrylate, polyethylene,poly(styrene-ethylene-butylene-styrene) (“SEBS”),poly(styrene-butadiene-styrene) (“SBS”),poly(styrene-isoprene-styrene)(“SIS”), and other similar thermoplasticelastomers, or any copolymer, mixture, or combination thereof. The oralproduct can also include a plasticizer dispersed in the mouth-stablepolymer matrix. For example, the plasticizer can be propylene glycol,glycerin, vegetable oil, triglycerides, or a combination thereof. Theoral product can also include a sweetener and/or sugar alcoholsdispersed in the body. The sweetener can be saccharine, sucralose,aspartame, acesulfame potassium, or a combination thereof. In somecases, an oral product can include one or more sugar alcohols selectedfrom the group of sorbitol, xylitol, mannitol, maltitol, isomalt, anderythritol or combinations thereof.

The oral product, according to certain embodiments, is substantiallyfree of tobacco plant tissue. Nicotine added to the oral product can beeither synthetic or derived from tobacco. In some embodiments, the oralproduct includes between 0.1 mg and 6 mg nicotine. The oral products canalso include an additive selected from the group consisting of minerals,vitamins, dietary supplements, nutraceuticals, energizing agents,soothing agents, amino acids, chemsthetic agents, antioxidants,botanicals, teeth whitening agents, therapeutic agents, or a combinationthereof. The nicotine and/or other additives can be absorbed into thecellulosic fibers and polymer matrix. The oral product, according tosome embodiments, includes exhausted-tobacco fibers as the cellulosicfibers. In some embodiments, the oral product includes tobacco fibers.

The oral product's body can have at least 10 weight percent cellulosicfibers. The cellulosic fibers can be derived from plant tissue. In someembodiments, the cellulosic fibers includes cellulose. The cellulosicfibers can further include lignin and/or lipids. The cellulosic fiberscan be non-tobacco cellulosic fibers. For example, the cellulosic fiberscan be selected from the following: sugar beet fiber, wood pulp fiber,cotton fiber, bran fiber, citrus pulp fiber, grass fiber, willow fiber,poplar fiber, and combinations thereof. The cellulosic fibers may alsobe chemically treated prior to use. For example, the cellulosic fiberscan be CMC, HPMC, HPC, or other treated cellulosic material.

The oral product can include flavorants. The flavorants can be naturalor artificial. Flavorants can be selected from the following: licorice,wintergreen, cherry and berry type flavorants, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon,apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot,geranium, honey essence, rose oil, vanilla, lemon oil, orange oil,Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol,ylang ylang, sage, fennel, pimenta, ginger, anise, coriander, coffee,mint oils from a species of the genus Mentha, cocoa, and combinationsthereof. Synthetic flavorants can also be used. In certain embodiments,a combination of flavorants can be combined to imitate a tobacco flavor.The particular combination of flavorants can be selected from theflavorants that are generally recognized as safe (“GRAS”). Flavorantscan also be included in the oral product as encapsulated flavorants.

The body of the oral product can have a variety of different shapes,some of which include disk, shield, rectangle, square, triangle, oval,or another appropiate shape. In some cases, the oral product has roundedcorners to enhance mouth feel. According to certain embodiments, thebody can have a length or width of between 5 mm and 25 mm and athickness of between 1 mm and 10 mm.

The oral product's body can be compressible and springy. In someembodiments, the body has a compressibility @ 250 N of less than 95%, orless than 90%. In some embodiments, the body has a compressibility of @250 N of between 45% and 95%. The oral product's body can have acompressibility @ 425 N of less than 99%. For example, the body can havea compressibility @ 425 N of between 60% and 98%. The body can also havea percentage of springiness of at least 20%, at least 30%, at least 40%,at least 50%, at least 60%, at least 70%, at least 75%, or at least 80%.For example, the body can have a percentage of springiness of between75% and −95%.

The oral product can also include an antioxidant. In some embodiments,the oral product includes between 0.01 weight percent and 5.0 weightpercent antioxidant. Suitable antioxidants include ascorbyl palmitate,BHT, ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols,propyl gallate, tertiary butylhydroquinone (TBHQ), butylatedhydroxyanisole (BHA), Vitamin E, and derivatives thereof. Thecombination of antioxidant and nicotine can reduce the formation ofnicotine-N-oxide.

The oral product can include a combination of soluble fibers andinsoluble cellulosic fibers. In some embodiments, a ratio of solublefiber to cellulosic fibers can be between 1:60 and 60:1. In someembodiments, the soluble fibers can include maltodextrin. In someembodiments, the soluble fibers comprise starch. The soluble fibers canbe derived from corn. In general, another aspect of the subject matterdescribed in this specification is methods of making and using the oralproduct. The methods of making the oral product can include the actionsof extruding a mouth-stable polymer having cellulosic fibers and/or oneor more additives dispersed therein.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pair of oral products.

FIGS. 2A-20 illustrate various exemplary shapes of oral products.

DETAILED DESCRIPTION

The oral products described herein include a mouth-stable polymermatrix, cellulosic fibers, and one or more mouth-soluble binders. Insome cases, the oral products can include one or more additives can bedispersed in the mouth-stable polymer matrix such that the one or moreadditives are released from the oral product when the oral product isreceived within the oral cavity and exposed to saliva. The oral productsdescribed herein can provide a favorable additive release profile andtactile experience.

Suitable mouth-stable polymers include thermoplastic elastomers such aspolyurethane. As used here, the term “mouth stable” means that thepolymer does not appreciably dissolve or disintegrate when exposed tosaliva within an oral cavity and at the normal human body temperature(e.g., about 98.6° F.) over a period of one hour. In addition tobiostable polymers, mouth-stable polymers can include biodegradablepolymers that breakdown over periods of days, weeks, months, and/oryears, but do not appreciably break down when held in an oral cavity andexposed to saliva for a period of one hour. In some embodiments, themouth-stable polymer is stable within an oral cavity and exposed tosaliva at the normal human body temperature for a period of at least 6hours, at least 12 hours, at least 24 hours, or at least 2 days.Accordingly, the oral products described herein can remain intact whenplaced within an oral cavity during a use period. After use, themouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

The mouth-stable polymer can have shape stability. In some cases, theoral product 110 can be chewed without significant and instantaneouspermanent plastic deformation. As the oral product 100 is chewed, it canbecome more pliable and additional additives can become available forrelease into the oral cavity. Some embodiments of the oral product 110can be adapted to remain non-sticky during and after use. Afterprolonged use, certain embodiments of the oral product 110 will expandand become flatter. The oral product, however, can retain the essence ofits original shape.

One or more additives are included in the oral product and adapted to bereleased from the oral product when the oral product is placed in anoral cavity. The oral product, in some embodiments, includes nicotine.The oral product can include a combination of nicotine, sweeteners, andflavorants to mimic the flavor profile and tactile experience of certaintobacco products (e.g., a pouched smokeless tobacco product).

In some embodiments, a nicotine-containing oral product can besubstantially free of tobacco plant tissue. As used herein, the term“tobacco plant tissue” refers to processed or non-processed cellulosicparts (e.g., leaves, stems) of a member of the genus Nicotiana, but doesnot include extracts of tobacco (e.g., tobacco-derived nicotine). Forexample, an oral product can include one or more organoleptic componentsextracted from raw or processed tobacco, yet be substantially free oftobacco plant tissue.

In addition to additives, sweeteners, and flavorants, the oral productcan also include fibers, fillers, plasticizers, and/or processing aids.Fibers can help provide access to the additives, sweeteners, and/orflavorants. As will be discussed below, fibers can provide channels foradditives, sweeteners, and/or flavorants to leach out of themouth-stable polymer matrix. The fiber-polymer-binder composite canabsorb one or more additives and provide a pathway for one or moreadditives to be released from the oral product. The fiber-polymer-bindercomposite can be porous. In some embodiments, the fiber-polymer-bindercomposite can have a plurality of pores having a pore diameter ofbetween 40 microns and 60 microns and a plurality of pores having a porediameter of between 1 micron and 10 microns. During use, saliva can beabsorbed into the fiber-polymer-binder composite to release theadditives, sweeteners, and/or flavorants. The absorbed saliva can enterthe pores and/or cause the fibers to expand, which can facilitatefurther release of additives, sweeteners, and/or flavorants. Mechanicalaction (e.g., chewing) of the oral product can facilitate the release ofthe additives, sweeteners, and/or flavorants.

Fillers can also be included in the mouth-stable polymer matrix to alterthe texture or pliability of the oral product. The mouth-stable polymermatrix can also include plasticizers, which can increase the softness ofthe oral product. Processing aids can also be present in the oralproduct and be used to facilitate shaping processes.

Oral Product Shapes and Packaging

FIG. 1 depicts an example of an oral product 110. The oral product 110has a disk shape. For example, the oral product 110 can have a diameterof about 12 mm and a thickness of about 2.5 mm.

Referring now to FIGS. 2A-2N, the oral product 110 can be molded intoany desired shape. For example, referring to FIGS. 2A-2L, the oralproduct 110A-L can be formed in a shape that promotes improved oralpositioning in the oral cavity, improved packaging characteristics, orboth. In some circumstances, the oral product 110A-L can be configuredto be: (A) an elliptical-shaped oral product 110A; (B) an elongatedelliptical-shaped oral product 110B; (C) semi-circular oral product110C; (D) square or rectangular-shaped oral product 110D; (E)football-shaped oral product 110E; (F) elongated rectangular-shaped oralproduct 110F; (G) boomerang-shaped oral product 110G; (H) rounded-edgerectangular-shaped oral product 110H; (I) teardrop- or comma-shaped oralproduct 110I; (J) bowtie-shaped oral product 110J; (K) peanut-shapedoral product 110K; and (L) shield-shaped oral product. Alternatively,the oral product can have different thicknesses or dimensionality, suchthat a beveled article (e.g., a wedge) is produced (see, for example,product 110M depicted in FIG. 2M) or a hemi-spherical shape is produced.In some embodiments, the oral product has a shield shape.

In addition or in the alternative to flavorants being included withinthe mouth-stable polymer matrix, flavorants can be included on anexterior of the oral product 110. For example, referring to FIG. 2N someembodiments of an oral product 110N can be equipped with flavor strips116.

Referring to FIG. 2O, particular embodiments of the oral product 110 canbe embossed or stamped with a design (e.g., a logo, an image, or thelike). For example, the oral product 110O can be embossed or stampedwith any type of design 117 including, but not limited to, a trademark,a product name, or any type of image. The design 117 can be formeddirectly into the oral product, arranged along the exterior of theproduct 110O. The design 117 can also be embossed or stamped into thoseembodiments with a dissolvable film 116 applied thereto.

In some embodiments, the oral product 110 or products 110A-0 can bewrapped or coated in an edible or dissolvable film, which may be opaque,substantially transparent, or translucent. The dissolvable film canreadily dissipate when the oral product 110 is placed in an oral cavity.In some embodiments, the oral product 110 can be coated with amouth-stable material. Exemplary coating materials include Beeswax,gelatin, acetylated monoglyceride, starch (e.g., native potato starch,high amylose starch, hydroxypropylated potato starch), Zein, Shellac,ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose,carboxymethyl cellulose, and combinations thereof. For example, acoating can include a combination of gelatin and methylcellulose. Forexample, coatings can include sugar alcohols, such as sorbitol, xylitol,mannitol, maltitol, isomalt, erythritol, maltodextrin, and/orpolysaccharides. In some embodiments, a coating material can include aplasticizer. In some case, a coating can include a colorant, aflavorant, and/or a one or more of the additives discussed above. Forexample, a coating can include nicotine to provide a user with aninitial nicotine burst. In some cases, the matrix of mouth-stablepolymer 120 can have surfaces roughened to improve the adherence of acoating. In some cases, a coating can provide a glossy or semi-glossyappearance, a smooth surface, and/or an appealing visual aesthetic(e.g., a nice color). In some embodiments, the coating (e.g., a beeswax,Zein, acetylated monoglyceride, and/or hydroxypropylated potato starchcoating) can provide soft mouth feel. In some embodiments, the coating(e.g., a methylcellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, ethyl cellulose, and/or gelatin coating) can provide a hardouter coating.

One or more oral products 110 can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 110 can be packaged in a container having a lid. In otherembodiments, a plurality of oral products 110 can be stacked andpackaged in a paper, plastic, and/or aluminum foil tube. The packagingcan have a child-resistant lid.

The oral product 110 can also include additional elements. In someembodiments, a mouth-stable polymer matrix including nicotine or aderivative thereof can be attached to a rod, tube, or stick.

Oral Product Properties

The oral product 110 can provide a favorable tactile experience (e.g.,mouth feel). The oral product 110 can also retain its shape duringprocessing, shipping, handling, and optionally use. As noted above, theoral product 110 includes a mouth-stable polymer matrix that does notappreciably dissolve or disintegrate when placed in an oral cavity andexposed to saliva. The mouth-soluble binder, however, can dissolveslowly to modify the flavor release profile and textural attributes ofthe oral product. The oral product 110 can have an elasticity allowingan adult consumer to work the product within the mouth. In someembodiments, the oral product 110 has at least some shape memory andthus can return to shape after being squeezed between teeth in an oralcavity. Working of the oral product 110 within the oral cavity canaccelerate the release of the additives, sweeteners, and/or flavorantswithin the mouth-stable polymer matrix.

During use, the oral product 110 can absorb saliva into thepolymer-fiber-binder matrix. The saliva can cause thepolymer-fiber-binder matrix to swell, which can further increase accessto different sections of the polymer-fiber matrix. The mouth-solublebinder can provide a modified flavor release provide that slowlydissolves to gradually increase access to additives, sweeteners, and/orflavorants within the mouth-stable polymer matrix. Physical activity,such as chewing of the product in the mouth, can also accelerate thepolymer-matrix swelling and therefore the release of additives. As theproduct is chewed, saliva can access different sections of thepolymer-fiber-binder matrix. The mouth-stable polymer can have shapestability. In some cases, the oral product 110 can be chewed withoutsignificant and instantaneous permanent plastic deformation (such asthat experienced by a chewing gum when chewed). As the oral product 100is chewed, it can become more pliable and additional additives canbecome available for release into the oral cavity. Some embodiments ofthe oral product 110 can be adapted to remain non-sticky during andafter use. After prolonged use, certain embodiments of the oral product110 will expand and become flatter. The oral product, however, canretain the essence of its original shape. The amount of deformation willdepend on the duration of use and an amount of mouth force used. As theproduct is used, it can increase in both weight and volume, due to theswelling. With greater the physical manipulation, the oral product 110will have a greater amount of swelling and thus have a larger weightgain. In certain embodiments, the oral product 110 will have an increasein weight of between 4 and 75 percent when chewed by an adult consumerfor 30 minutes.

One way of characterizing the properties of the oral product is bymeasuring the compressibility and springiness of the product. Thecompressibility can be calculated as a percentage of reduction inthickness of the sample when the sample is compressed with astandardized probe with a particular force. As used herein, the term“compression @ 250 N test” defines a test of a sample where the sampleis placed on a flat stationary surface and twice compressed with a 10mm-diameter-sphere-tipped probe with a force of 250 N with a hold timeof 30 seconds between compressions. The “percentage of compression @ 250N” is the maximum amount of reduction in thickness of the sample duringthe compression @250 N test. For example, if a 3 mm thick sample iscompressed to a minimum thickness of 1.5 mm during either of the twocompressions, the sample is said to have a 50% compression @ 250 N. Asused herein, the term “compression @ 425 N test” defines a test of asample where the sample is placed on a flat stationary surface and twicecompressed with a 10 mm-diameter-sphere-tipped probe with a force of 425N with a hold time of 30 seconds between compressions. For comparison, anormal human bite force is typically between 400 and 500 N.

In some embodiments, the oral product 110 has a percentage ofcompression @ 250 N of less than 95%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 250 N of less than 90%. Incertain embodiments, the oral product 110 has a percentage ofcompression @ 250 N of at least 10%, at least 25%, at least 40%, atleast 60%, at least 70%, at least 80%, or at least 90%. For example, theoral product can have a percentage of compression @ 250 N of between 80%and 90%. In some embodiments, the oral product 110 has a percentage ofcompression @ 425 N of less than 99%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 425 N of less than 98%,less than 97%, or less than 96%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 425 N of at least 10%, atleast 25%, at least 50%, or at least 60%. For example, the oral productcan have a percentage of compression @ 425 N of between 65% and 98%.FIG. 9A, discussed in more detail below, depicts examples of compressiontest results for certain embodiments of oral products, for gum (bothchewed and fresh), and for an eraser.

The springiness of a sample can be measured by measuring the percentageof recovery after a sample is compressed. As used herein, the term“percentage of springiness” means the percentage of thickness recoveryof the sample during a 30 second recovery time after being compressed bythe compression @ 425 N test using the 10 mm-diameter-sphere-tippedprobe. For example, if a sample is compressed from an original thicknessof 3.0 mm to a thickness of 2.0 mm and then recovers to 2.5 mm after 30seconds, the springiness of the sample would be 50%. In someembodiments, the oral product 110 has a percentage of springiness of atleast 20%. In certain embodiments, the oral product 110 has a percentageof springiness of at least 40%, at least 50%, at least 60%, at least70%, at least 75%, at least 80%, or at least 90%. In certainembodiments, the percentage of springiness is less than 95%, less than90%. For example, the oral product can have a percentage of springinessof between 75% and 95%. In some cases, oral products can have acompression @250N that ranges from 80% to 90%, a compression @425N thatranges from 90% to 99%, and/or a springiness that ranges from 80% to96%.

The particular materials used in the oral product 110 and the processingtechniques discussed below can have an impact on the compressibility andspringiness of the oral product. In addition to different materials havedifferent compressibility and springiness properties, the incorporationof air bubbles or channels, or different fillers and/or fibers can alsohave an impact on the elasticity and pliability of the oral product.Additionally, the material properties of the overall oral product 110can change as additives are released. In some embodiments, fibers and/orfillers can also dissolve or disintegrate during use and thus alter thematerial properties of the oral product 110 during use.

The oral product 110 can have a variety of colors. In some embodiments,the oral product 110 has an off-white color. In other embodiments,natural and artificial coloring can be added to the mouth-stable polymerbefore or during the molding process to form oral products 110 having apredetermined color. Encapsulated flavors can be added during theextrusion process to create speckles, patterns or dots within the oralproduct.

Polymers

The mouth-stable polymer can be a variety of different biocompatible andbiostable polymers. In some cases, a mouth-stable polymer matrix caninclude a single type of polymer (e.g., polyurethane). In some cases, amouth-stable polymer matrix can include a blend of different polymers.In some embodiments, the mouth-stable polymer is a polymer generallyrecognized as safe by an appropriate regulatory agency. In someembodiments, the polymer is a thermoplastic polymer. The polymer canalso be a thermoplastic elastomer. For example, suitable mouth-stablepolymers include polyurethanes, silicon polymers, polyesters,polyacrylates, polyethylenes, polypropylenes, polyetheramides,polystyrenes (e.g., acrylonitrile butadiene styrene, high impactpolystyrenes (HIPS)) polyvinyl alcohols, polyvinyl acetates, polyvinylchlorides, polybutyl acetates, butyl rubbers (e.g., polyisobutylenes),SEBS, SBS, SIS, and mixtures and copolymers thereof. Many suitablemouth-stable polymers exhibit undetectable dissolution or disintegrationwhen held in the mouth for one hour. However, biocompatible,biodegradable polymers that exhibit less 25% dissolution ordisintegration when held in the mouth for one hour, 6 hours, 12 hours,24 hours, or 48 hours are also suitable for use as mouth-stable polymersin an oral product. In certain embodiments, the mouth-stable polymer isfood-grade or medical-grade polymers (e.g., medical-grade polyurethane).

The mouth-stable polymer forms the mouth-stable polymer matrix of theoral product 110. In some embodiments, the oral product includes atleast 10 weight percent of one or more mouth-stable polymers. In certainembodiments, the oral product includes at least 20 weight percent, atleast 30 weight percent, at least 40 weight percent, at least 50 weightpercent, at least 60 weight percent, at least 70 weight percent, atleast 80 weight percent, or at least 90 weight percent of one or moremouth-stable polymers. In certain embodiments, the oral product includesbetween 10 and 90 weight percent of one or more mouth-stable polymers.Accordingly to some embodiments, the oral product includes between 40and 80 weight percent of the mouth-stable polymers. Some embodiments ofthe oral product have between 55 and 70 weight percent polymers.

The mouth-stable polymer according to certain embodiments has a flexuralmodulus of at least 5 MPa when tested according to ASTM Testing MethodD790 or ISO 178 at 23 degrees Celsius. In some embodiments, the flexuralmodulus is at least 10 MPa. For example, the flexural modulus can bebetween 10 MPa and 30 MPa. In some embodiments, the mouth-stable polymeris a grade that complies with food-contact regulations applicable in oneor more countries (e.g., US FDA regulations). In some embodiments, themouth-stable polymer can be a polyurethane, SIS, or other thermalplastic elastomer meeting the requirements of the FDA-modified ISO10993, Part 1 “Biological Evaluation of Medical Devices” tests withhuman tissue contact time of 30 days or less. The mouth-stable polymercan have a shore Hardness of 50D or softer, a melt flow index of 3 g/10min at 200° C./10 kg, a tensile strength of 10 MPa or more (using ISO37), and a ultimate elongation of less than 100% (using ISO 37).

Cellulosic Fibers

The oral product can include cellulosic fibers within the mouth-stablepolymer matrix. As will be discussed below, the cellulosic fibers can bemixed with the mouth-stable polymer and the mouth-soluble binder priorto or during an extrusion process. The cellulosic fibers can providepassages in the mouth-stable polymer matrix, which can permit certainadditives within the mouth-stable polymer matrix to be released into anoral cavity when the oral product is received in an oral cavity andexposed to saliva. The additives can be absorbed or dispersed infiber-polymer-binder composite and/or form pockets within themouth-stable polymer matrix, which can be accessed via the fibers 130.

The cellulosic fibers can be obtained by processing plant tissue.Suitable sources for cellulosic fibers include wood pulp, cotton, sugarbeets, bran, citrus pulp fiber, switch grass and other grasses, Salix(willow), tea, opulus (poplar), or combinations thereof. The cellulosicfibers may also be chemically treated prior to use. For example, thecellulosic fibers can be CMC, HPMC, HPC, or other treated cellulosicmaterial. In some embodiments, the cellulosic fibers can be chopped orshredded plant tissue and, as such, contain various compounds naturallypresent in the tissue in addition to cellulosic fibers, e.g., lignin,lipids, or flavor compounds. In some embodiments, the cellulosic fiberscan be chopped or shredded plant tissue comprising various naturalflavors, sweeteners, or active ingredients. In some embodiments, theoral product 110 can include nicotine as an additive (optionally withadditional sweeteners and flavors) and non-tobacco cellulosic fiber, andthus be substantially free of tobacco plant tissue.

The cellulosic fibers can have a variety of dimensions. The dimensionsof the fibers (in addition to the amount) can impact the releasecharacteristics of the additives. For example, cellulosic fibers can behydrophilic, thus water soluble additives (e.g., nicotine) canpreferentially be absorbed in fiber-polymer-binder composite. In certainembodiments, the cellulosic fiber can be processed to have an averagefiber size of less than 200 micrometers. In particular embodiments, thefibers are between 75 and 125 micrometers. In other embodiments, thefibers are processed to have a size of 75 micrometers or less.

The oral product 110 can also include soluble fibers in addition tocellulosic fibers. The soluble fibers can be adapted to dissolve whenexposed to saliva when the oral product 110 is received in an oralcavity. In some embodiments, the soluble fiber can be a maltodextrin.The maltodextrin can be derived from corn. For example, Soluble DietaryFiber can be included in an oral product 110. Soluble fibers can be usedalone or with cellulosic fibers to provide channels for additives to bereleased from the oral product 110. As the soluble fibers dissolve, theoral product 110 can become more flexible and the additional channelscan open up to permit the release of additional additive deposits.Suitable soluble fibers include psyllium fibers. The ratio of soluble toinsoluble fiber can impact the softness of texture of the oral product110. The ratio of soluble to insoluble fiber can also impact thecompressibility of the oral product 110. In some embodiments, a ratio ofsoluble to insoluble fiber is between 1:60 and 60:1. In someembodiments, the ratio of soluble to insoluble fiber is greater than1:50, greater than 1:40, greater than 1:30, greater than 1:20, greaterthan 1:10, or greater than 1:5. In some embodiments, the ratio ofsoluble to insoluble fiber is less than 1:1, less than 1:2, less than1:5, less than 1:10, less than 1:20, or less that 1:30. In some case, anoral product having a mixture of soluble and insoluble fibers can have apercentage of compression @ 250 N of between 60 percent and 98 percent,between 65 percent and 95 percent, between 70 percent and 90 percent, orbetween 80 and 89 percent. In some embodiments, the cellulosic fiberscan be partially soluble. For example, sugar beet fibers can partiallydissolve during use.

In some cases, an oral product can contain cellulosic fibers derivedfrom tobacco. By “tobacco” it is meant a part, e.g., leaves, flowers,and stems, of a member of the genus Nicotiana. Exemplary species oftobacco include N. rustica, N. tabacum, N. tomentosiformis, and N.sylvestris. Suitable tobacco fibers can include tobacco fibers formedfrom fermented and unfermented tobaccos, dark air-cured, darkfire-cured, burley, flue cured, and cigar filler or wrapper, as well asthe products from the whole leaf stemming operation. For example,tobacco can be conditioned by heating, sweating and/or pasteurizingsteps as described in U.S. Publication Nos. 2004/0118422 or2005/0178398. Fermenting typically is characterized by high initialmoisture content, heat generation, and a 10 to 20% loss of dry weight.See e.g., U.S. Pat. Nos. 4,528,993; 4,660,577; 4,848,373; and 5,372,149.Cured, or cured and fermented tobacco can be further processed (e.g.,cut, expanded, blended, milled or comminuted) prior to incorporationinto the mouth-stable polymer matrix. The tobacco fibers, in someembodiments, include cured long cut fermented moist tobacco having anoven volatiles content of between 48 and 50 weight percent prior tomixing with the mouth-stable polymer, the mouth-soluble binder, andoptionally flavorants and/or other additives.

The tobacco fibers can, in some embodiments, be prepared from or includeleaf tobacco from tobacco plants having less than 20 μg of DVT per cm2of green leaf tissue. For example, the tobacco can be selected from thetobaccos described in U.S. Patent Publication No. 2008/0209586, which ishereby incorporated by reference. Tobacco compositions containingtobacco from such low-DVT varieties exhibit improved flavorcharacteristics in sensory panel evaluations when compared to tobacco ortobacco compositions that do not have reduced levels of DVTs.

Mouth-Soluble Binder

Mouth-soluble binders suitable for use in the oral product describedherein include orally compatible polymers, such as cellulosics (e.g.,carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC),hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), andmethyl cellulose (MC)); natural polymers (e.g., starches and modifiedstarches, konjac, collagen, inulin, soy protein, whey protein, casein,and wheat gluten); seaweed-derived polymers (e.g., carrageenan (kappa,iota, and lambda); alginates, (and propylene glycol alginate),microbial-derived polymers (e.g., xanthan, dextrin, pullulan, curdlan,and gellan); extracts (e.g., locust bean gum, guar gum, tara gum, gumtragacanth, pectin (lo methoxy and amidated), agar, zein, karaya,gelatin, psyllium seed, chitin, and chitosan), exudates (e.g., gumacacia (arabic) and shellac), synthetic polymers (e.g., polyvinylpyrrolidone, polyethylene oxide, and polyvinyl alcohol)), and pectin.

The mouth-soluble binder, in some embodiments, is guar gum, xanthan,cellulose, or a combination thereof. The cellulose can be carboxymethylcellulose (CMC). Guar gum, xanthan, CMC, and some combinations thereofcan be obtained from, for example, TIC Gums Inc., located in WhiteMarsh, Md. and at www.ticgums.com. Guar gum is sold by TIC Gums Inc.under the trade name GUARNT. Carboxymethyl cellulose (CMC) is sold byTIC Gums Inc. under the trade name TICALOSE. Xanthan is sold by TIC GumsInc. under the trade name TICAXAN. TIC Gums Inc. also sells some mixedbinders, such as the mixed binder systems sold under the trade namesTICALOID and TICAFILM. In some embodiments, TICALOID LITE Powder is usedas the binder in the oral products.

The mouth-soluble binder can be present in amounts that allow the oralproduct 110 to have the material properties described herein. Thespecific amount of mouth-soluble binder used to achieve the particularmaterial properties can depend, in part, on the type of mouth-solublebinder used. In some embodiments, the oral products 110 include at least0.1 weight percent mouth-soluble binder. The oral products 110 have, insome embodiments, less than 5.0 weight percent mouth-soluble binder. Insome embodiments, the oral products 110 have between 0.0.01 and 2.0weight percent mouth-soluble binder. In some embodiments, the oralproducts 110 have between 0.1 and 1 weight percent binder.

Additives

A variety of additives can be included in the oral product 110. Theadditives can include alkaloids (e.g., nicotine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemsthetic agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. In certain embodiments, the additives includenicotine, sweeteners, and flavorants. With certain combinations ofnicotine, sweeteners, and flavorants, the oral product may provide aflavor profile and tactile experience similar to certain tobaccoproducts.

Nicotine

Nicotine within the oral product can be tobacco-derived nicotine,synthetic nicotine, or a combination thereof. In certain embodiments,the oral product includes between 0.1 mg and 6.0 mg of nicotine. In someof these embodiments, the oral product includes between 1.0 mg and 3.0mg of nicotine.

Tobacco-derived nicotine can include one or more other tobaccoorganoleptic components other than nicotine. The tobacco-derivednicotine can be extracted from raw (e.g., green leaf) tobacco and/orprocessed tobacco. Processed tobaccos can include fermented andunfermented tobaccos, dark air-cured, dark fire cured, burley, fluecured, and cigar filler or wrapper, as well as the products from thewhole leaf stemming operation. The tobacco can also be conditioned byheating, sweating and/or pasteurizing steps as described in U.S.Publication Nos. 2004/0118422 or 2005/0178398. Fermenting typically ischaracterized by high initial moisture content, heat generation, and a10 to 20% loss of dry weight. See, e.g., U.S. Pat. Nos. 4,528,993;4,660,577; 4,848,373; and 5,372,149. By processing the tobacco prior toextracting nicotine and other organoleptic components, thetobacco-derived nicotine may include ingredients that provide afavorable experience.

The tobacco-derived nicotine can be obtained by mixing cured andfermented tobacco with water or another solvent (e.g., ethanol) followedby removing the insoluble tobacco material. The tobacco extract may befurther concentrated or purified. In some embodiments, select tobaccoconstituents can be removed. Nicotine can also be extracted from tobaccoin the methods described in the following U.S. Pat. Nos. 2,162,738;3,139,436; 3,396,735; 4,153,063; 4,448,208; and 5,487,792.

The nicotine can also be purchased from commercial sources, whethertobacco-derived or synthetic. In other embodiments, the oral product caninclude a derivative of nicotine (e.g., a salt of nicotine).

Antioxidants

The oral product 110 can also include one or more antioxidants. In someembodiments, an oral product 110 can include a combination of nicotineand antioxidants. Antioxidants can result in a significant reduction inthe conversion of nicotine into nicotine-N-oxide when compared to oralproducts without antioxidants. In some cases, an oral product caninclude 0.01 and 5.00 weight percent antioxidant, between 0.05 and 1.0weight percent antioxidant, between 0.10 and 0.75 weigh percentantioxidant, or between 0.15 and 0.5 weight percent antioxidant.Suitable examples of antioxidants include ascorbyl palmitate (a vitaminC ester), BHT, ascorbic acid (Vitamin C), and sodium ascorbate (VitaminC salt). In some embodiments, monosterol citrate, tocopherols, propylgallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole(BHA), Vitamin E, or a derivative thereof can be used as theantioxidant. For example, ascorbyl palmitate can be the antioxidant insome embodiments. Antioxidants can be incorporated into the polymer(e.g., polyurethane) during an extrusion process or after the polymer isextruded (e.g., during a post-extrusion flavoring process).

In some cases, the oral product 110 can have a conversion of less than0.50% of nicotine into nicotine-N-oxide after aging the oral product 110for 2 weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.20% of nicotine intonicotine-N-oxide after aging the oral product 110 for 2 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.70% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 4 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.30% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 4 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.80% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 6weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.40% of nicotine intonicotine-N-oxide after aging the oral product 110 for 6 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.30% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 6 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.85% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 8 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.50% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 8weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.85% of nicotine intonicotine-N-oxide after aging the oral product 110 for 10 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.55% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 10 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.95% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 12 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.60% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 12weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 1.07% of nicotine intonicotine-N-oxide after aging the oral product 110 for 30 weeks at 25° C.and 65% relative humidity. The presence of antioxidant can also reducethe formation of other tobacco derived impurities, such as Cotinine andmyosime.

Sweeteners

A variety of synthetic and/or natural sweeteners can be used asadditives in the oral product 110. Suitable natural sweeteners includesugars, for example, monosaccharides, disaccharides, and/orpolysaccharide sugars, and/or mixtures of two or more sugars. Accordingto some embodiments, the oral product 110 includes one or more of thefollowing: sucrose or table sugar; honey or a mixture of low molecularweight sugars not including sucrose; glucose or grape sugar or cornsugar or dextrose; molasses; corn sweetener; corn syrup or glucosesyrup; fructose or fruit sugar; lactose or milk sugar; maltose or maltsugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol ord-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures orblends of one or more of these ingredients. The oral product 110 canalso include non-nutritive sweeteners. Suitable non-nutritive sweetenersinclude: stevia, saccharin; Aspartame; sucralose; or acesulfamepotassium.

Flavorants

The oral product 110 can optionally include one or more flavorants. Theflavorants can be natural or artificial. For example, suitableflavorants include wintergreen, cherry and berry type flavorants,various liqueurs and liquors (such as Dramboui, bourbon, scotch, andwhiskey) spearmint, peppermint, lavender, cinnamon, cardamon, apiumgraveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium,honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage,fennel, pimenta, ginger, anise, coriander, coffee, liquorish, and mintoils from a species of the genus Mentha, and encapsulated flavors. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. Incertain embodiments, a combination of flavorants can be combined toimitate a tobacco flavor. The particular combination of flavorants canbe selected from the flavorants that are generally recognized as safe(“GRAS”) in a particular country, such as the United States. Flavorantscan also be included in the oral product as encapsulated flavorants.

In some embodiments, the flavorants in the oral product 110 are limitedto less than 20 weight percent in sum. In some embodiments, theflavorants in the oral product 110 are limited to be less than 10 weightpercent in sum. For example, certain flavorants can be included in theoral product 110 in amounts of about 1 weight percent to 5 weightpercent.

Other Additives

The oral product 110 may optionally include other additives. Forexample, these additives can include non-nicotine alkaloids, dietaryminerals, vitamins, dietary supplements, therapeutic agents, andfillers.

Oral products 110 can also include vitamins, dietary minerals, otherdietary supplements, and/or therapeutic agents. For example, suitablevitamins include vitamins A, B1, B2, B6, C, D2, D3, E, F, K, and P. Forexample, an oral product 110 can include C-vitamins with nicotine.Suitable dietary minerals include calcium (as carbonate, citrate, etc.)or magnesium (as oxide, etc.), chromium (usually as picolinate), andiron (as bis-glycinate). One or more dietary minerals could be includedin an oral product with or without the use of other additives. Otherdietary supplements and/or therapeutic agents can also be included asadditives.

In some embodiments, the oral product 110 includes a therapeutic agentthat is preferable absorbed transbuccally. For example, so therapeuticagents do not pass into the blood stream if they are swallowed.Exemplary therapeutic agents that can be included in an oral product 110provided herein can include Gerd, Buprenorphin, Nitroglycerin,Diclofenac, Fentanyl, Carbamazepine, Galantamine, Acyclovir,Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone, Estradiol,Progesterone, Calcitonin, Fluorouracil, Naltrexone, Odansetron,Decitabine, Selegiline, Lamotrigine, and Prochlorperazine. For example,an oral product 110 can include Buprenorphine and be used for paintreatment. In some embodiments, an oral product 110 can includeNitroglycerin and be used for Angina Pectoris treatment. Because of therelease properties of the oral product 110, therapeutic agents includedtherein can be released at a rate such that a majority of thetherapeutic agent is absorbed transbuccally, rather than swallowed.

The oral product 110 can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some embodiments, theamount of filler in the oral product 110 is limited to less than 10weight percent in sum. In some embodiments, the amount of filler in theoral product 110 is limited to be less than 5 weight percent in sum. Insome embodiments, the fillers are mouth stable. In other embodiments,the fillers can dissolve or disintegrate during use and thus result inan oral product that becomes more pliable during use.

In some embodiments, the oral product 110 can include nicotine as anadditive (optionally with additional sweeteners and flavors) andnon-tobacco cellulosic fiber, and thus be substantially free of tobaccoplant tissue.

Plasticizers

The oral product 110 can also include one or more plasticizers.Plasticizers can soften the final oral product and thus increase itsflexibility. Plasticizers work by embedding themselves between thechains of polymers, spacing them apart (increasing the “free volume”),and thus significantly lowering the glass transition temperature for theplastic and making it softer. Suitable plasticizers include propyleneglycol, glycerin, vegetable oil, and medium chain triglycerides. In someembodiments, the plasticizer can include phthalates. Esters ofpolycarboxylic acids with linear or branched aliphatic alcohols ofmoderate chain length can also be used as plasticizers. Moreover,plasticizers can facilitate the extrusion processes described below. Insome embodiments, the oral product 110 can include up to 20 weightpercent plasticizer. In some embodiments, the oral product 110 includesbetween 0.5 and 10 weight percent plasticizer, the oral product 110 caninclude between 1 and 8 weight percent plasticizer, or between 2 and 4weight percent plasticizer. For example, an oral product comprising apolyurethane polymer matrix and include about 3 to 6.5 weight percent ofpropylene glycol.

Molding Processes

The oral product 110 can be produced by extruding a mouth-stable polymer(e.g., polyurethane) with fibers (e.g., cellulosic fiber) and/oradditive (e.g., nicotine) to form a rod of a mouth-stable polymer matrixincluding fibers and/or additives. The rod is cut into individual oralproducts 110.

For example, a mouth-stable polymer (e.g., polyurethane) can beintroduced into an extruder for extrusion along with cellulosic fibersand one or more mouth-soluble binders. For example, the mouth-solublebinders can include guar gum, xanthan, cellulose gum, or a combinationthereof. The mouth-soluble binders can either be pre-mixed with thecellulosic fibers or added separately into the extruder. The cellulosicfibers can be passed through a sieve prior to introduction into theextruder. A mixture of additives can also be introduced into theextruder. The mixture of additives can be a solution. The additives caninclude a plasticizer (e.g., propylene glycol) and a sweetener (e.g.,sucralose). The mixture of additives can also be provided in slurry formor a dry mix of powdered additives.

The polymer-fiber-binder combination can exit an extrusion die as a rodand onto a moving conveyor. The size of the extrusion die, the take awayspeed of the moving conveyor, the mixture of polymer-fiber-bindercombination, and the temperature of the mixture exiting the die can allhave an impact on the final diameter of the rod. The extrudedpolymer-fiber rod can then cut in a cutting process.

In addition to the methods described above, there are many methods formaking and shaping the oral products. In some embodiments, extruded andcut pieces can be introduced into a compression mold to form a finaloral product shape. In other embodiments, the oral product 110 can beinjection molded, compression molded, or injection-compression molded.Blocks of polymer, fiber, and/or additive can also be formed andmachined into a desired shape.

Examples

A series of oral products were produced by combining polyurethane,cellulosic fiber, -xanthan gum, guar gum, cellulose gum, nicotine,ascorbyl palmitate antioxidant, maltodextrin soluble fibers, propyleneglycol, sweeteners, and flavorants to produce a variety of oralproducts. The oral products were made by pre-blending certainingredients, extruding at least some of the ingredients together to forma rod, cutting the rod into oral products, and flavoring the oralproducts. A first pre-blended mixture was formed to include cellulosefiber, maltodextrin soluble fiber, xanthan gum, guar gum and cellulosegum. A second mixture include additional ingredients was also created.Polyurethane, the pre-blended mixture, and the second mixture were eachmetered into the extruder at a controlled feed rate, to form an extrudedrod. The extruded rod was cut and subsequently flavored. The pre-blendedmixture formed about 20-50 weight percent of the formed oral products.The formed oral products included between 40 weight percent and 85weight percent polyurethane. The formed oral products included between 1weight percent and 25 weight percent of the second mixture.

Product samples were cut to have a thickness of about 3 mm and subjectedto the compression @ 250 N test, the compression @ 425 N test, and thespringiness test discussed above. The oral products had a compression@250N ranging from 83% to 88%; a compression @425N ranging from 97% to99%; and a springiness ranging from 85% to 89%.

A series of oral products were also tested in a mastication test todetermine the additive release profile. Each sample was placed in amastication tester that manipulated the sample in a solution that mimicssaliva. At varying time intervals, samples were taken from themastication tester to determine the total amount of menthol and nicotinereleased. The results of this mastication test are shown in Table Ibelow.

TABLE I Average (n = 2) Relative Cumulative Concentration (mg/Piece)Time (min) STDEV Nicotine V-031513-S4-1 5 0.31 0.01 V-031513-S4-2 100.50 0.06 V-031513-S4-3 15 0.67 0.07 V-031513-S4-4 30 0.89 0.10V-031513-S4-5 45 1.08 0.12 V-031513-S4-6 60 1.19 0.04 MethanolV-031513-S4-1 5 0.18 0.02 V-031513-S4-2 10 0.33 0.00 V-031513-S4-3 150.45 0.02 V-031513-S4-4 30 0.53 0.02 V-031513-S4-5 45 0.67 0.01V-031513-S4-6 60 0.73 0.03

OTHER EMBODIMENTS

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. An oral product, comprising a body that is whollyreceivable in an oral cavity, the body comprising: a mouth-stablepolymer matrix; cellulosic fibers embedded in the mouth-stable polymermatrix; and mouth-soluble binder dispersed in the mouth-stable polymermatrix.
 2. The oral product of claim 1, wherein the mouth-stable polymermatrix comprises polyurethane.
 3. The oral product of claim 1, whereinthe mouth-stable polymer matrix comprises polyester, polyacrylate,polyethylene, SEBS, SBS, or a combination thereof.
 4. The oral productof claim 1, wherein the mouth-soluble binder comprises guar gum,xanthan, carboxymethyl cellulose, or a combination thereof.
 5. The oralproduct of claim 1, wherein the oral product includes between 0.1 weightpercent and 5.0 weight percent of mouth-soluble binder.
 6. The oralproduct of claim 1, further comprising a plasticizer dispersed in themouth-stable polymer matrix.
 7. The oral product of claim 1, furthercomprising a sweetener selected from the group consisting of saccharine,sucralose, aspartame, acesulfame potassium, isomaltulose, andcombinations thereof in the body.
 8. The oral product of claim 1,wherein the nicotine is tobacco-derived nicotine.
 9. The oral product ofclaim 1, wherein the oral product is substantially free of tobacco planttissue.
 10. The oral product of claim 1, further comprising an additiveselected from the group consisting of minerals, vitamins, dietarysupplements, nutraceuticals, energizing agents, soothing agents, aminoacids, chemsthetic agents, antioxidants, botanicals, teeth whiteningagents, therapeutic agents, and combinations thereof, wherein theadditive is dispersed in the body such that the additive is releasedwhen the body is held within a mouth of an adult consumer.
 11. The oralproduct of claim 1, further comprising a flavorant dispersed in the bodysuch that the flavorant is released when the body is held within a mouthof an adult consumer.
 12. The oral product of claim 1, wherein the bodyis shield shaped.
 13. The oral product of claim 1, wherein the body hasa diameter of between 5 mm and 25 mm and a thickness of between 1 mm and10 mm.
 14. The oral product of claim 1, wherein the body comprises atleast 10 weight percent cellulosic fibers.
 15. The oral product of claim1, wherein the cellulosic fibers are non-tobacco cellulosic fibers. 16.The oral product of claim 1, wherein the cellulosic fibers are sugarbeet fibers, wood pulp fiber, cotton fiber, bran fiber, citrus pulpfiber, grass fiber, willow fiber, and poplar fiber.
 17. The oral productof claim 1, wherein the body comprises at least 10 weight percent of themouth-stable polymer.
 18. The oral product of claim 1, wherein the bodycomprises between 0.1 mg and 6 mg nicotine.
 19. The oral product ofclaim 1, wherein the body has a compressibility @ 250 N of between 80%and 95%.
 20. The oral product of claim 1, wherein the body has apercentage of springiness of between 75% and 95%.
 21. The oral productof claim 1, further comprising an antioxidant.
 22. The oral product ofclaim 21, wherein the antioxidant is ascorbyl palmitate.
 23. The oralproduct of claim 1, further comprising a soluble fiber.
 24. The oralproduct of claim 23, wherein the ratio of soluble fiber to cellulosicfibers is between 1:60 and 60:1.
 25. The oral product of claim 23,wherein the soluble fibers comprise maltodextrin.
 26. A method offorming an oral product comprising: extruding a mouth-stable polymerhaving cellulosic fibers and a mouth-soluble binder dispersed therein;and dispersing nicotine or a derivative thereof within the mouth-stablepolymer during or after the extruding step.
 27. An oral product,comprising a body that is wholly receivable in an oral cavity, the bodycomprising: a mouth-stable polymer matrix; tobacco fibers embedded inthe mouth-stable polymer matrix; and mouth-soluble binder dispersed inthe mouth-stable polymer matrix.
 28. The oral product of claim 27,wherein the mouth-stable polymer matrix comprises a polyurethane and themouth-soluble binder comprises guar gum, xanthan, carboxymethylcellulose or a combination thereof.
 29. The oral product of claim 27,further comprising an additive selected from the group consisting offlavorants, minerals, vitamins, dietary supplements, nutraceuticals,energizing agents, soothing agents, amino acids, chemsthetic agents,antioxidants, botanicals, teeth whitening agents, therapeutic agents,and combinations thereof.